Gingival RecessionNCT05045586
MCAT With HA and sCTG Compared With sCTG Alone for Treatment of Multiple Gingival Recession: Clinical Trial
A study testing The tunnel technique for root coverage with CTG without Cross-linked Hyaluronic Acid and The tunnel technique for root coverage with CTG andCross-linked Hyaluronic Acid in people with Gingival Recession, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Microsurgical tunneling flap procedures using connective tissue grafts (CTG) are predictable for treating teeth with gingival recessions. Cross-linked hyaluronic acid can be used in conjunction with subepithelial palatal connective tissue grafts to improve postsurgical results. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- The tunnel technique for root coverage with CTG without Cross-linked Hyaluronic Acid and The tunnel technique for root coverage with CTG andCross-linked Hyaluronic Acid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 sitePoland
- Study dates
- 15 Sep 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥ 18 years
- Bilateral multiple gingival recessions in homologous teeth
Who cannot join
- Full-mouth plaque index ≥ 20% (Ainamo \& Bay 1975)
- Full-mouth sulcus bleeding index ≥ 15% (Mühlemann \& Son 1971)
- Smoking
- Systemic diseases with compromised healing potential of infectious diseases
- Drugs affecting periodontal health / healing
- Pregnant and lactating females
- Previous periodontal surgery in the area
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
Warsaw, Mazowsze, 00-246
Batlomiej Gorski, DDS, PhD, +48 22 502 20 99
About this study
Official title: Modified Coronally Advanced Tunnel With Cross-linked Hyaluronic Acid in Addition to Connective Tissue Graft Compared With Subepithelial Connective Tissue Graft Alone for Treatment of Multiple Gingival Recession: Randomized Clinical Trial
Microsurgical tunneling flap procedures using connective tissue grafts (CTG) are predictable for treating teeth with gingival recessions. Cross-linked hyaluronic acid can be used in conjunction with subepithelial palatal connective tissue grafts to improve postsurgical results. The aim of this study is to evaluate clinically the use of tunnel technique with CTG and cross-linked hyaluronic acid in addition to CTG alone for the treatment of multiple gingival recessions.
Read the detailed description
The treatment of multiple adjacent recession appears to be challenging for the clinician due to large surgical field, variation in teeth position in the dental arch (prominent roots), variation in recession size, thin phenotype and insufficient keratinized tissue in many teeth. Surgical treatment of all multiple recession in one dental arch during one session appears to be optimum. Surgical treatment time is longer, however patient doesn't need to undergo multiple surgeries, pharmacological therapies and postsurgical instructions. Esthetic concern seems to be one of the most common complaints from patients. Among utilized surgical techniques tunneling flap procedures using connective tissue grafts (CTG) with or without biologics such as an enamel matrix derivative (EMD) or hyaluronic acid (HA) provided the most successful outcomes for the treatment. Cross-linked hyaluronic acid can be used in conjunction with subepithelial palatal connective tissue grafts to improve postsurgical results and improving healing process. The aim of this study is to evaluate clinically the use of tunnel technique with CTG and cross-linked hyaluronic acid in addition to CTG alone for the treatment of multiple gingival recessions.
- Conditions
- Gingival Recession
- Being tested
- The tunnel technique for root coverage with CTG without Cross-linked Hyaluronic Acid, The tunnel technique for root coverage with CTG andCross-linked Hyaluronic Acid
- Keywords
- connective tissue graft, tunneling flap procedure, hyaluronic acid
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The tunnel technique for root coverage with CTG without Cross-linked Hyaluronic AcidDevice
The tunnel technique for root coverage with CTG without Cross-linked Hyaluronic Acid
The tunnel technique for root coverage with CTG andCross-linked Hyaluronic AcidDevice
The tunnel technique for root coverage with CTG andCross-linked Hyaluronic Acid
| Study group | Role | What they receive |
|---|---|---|
| Modified Coronally Advanced Tunnel With Connective Tissue Graft | Experimental | Procedure: A modified microsurgical tunnel technique by Zuhr et al. (2007). Initial sulcular incisions with a microsurgical blade are followed by a split-thickness buccal flap preparations using the tunneling knives. The preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The graft is inserted into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures. Receives: Device: The tunnel technique for root coverage with CTG without Cross-linked Hyaluronic Acid |
| MCAT With Cross-linked Hyaluronic Acid in Addition to CTG | Active comparator | Procedure: A modified microsurgical tunnel technique by Zuhr et al. (2007). Initial sulcular incisions with a microsurgical blade are followed by a split-thickness buccal flap preparations using the tunneling knives. The preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The root surfaces are applied with cross-linked hyaluronic acid. The graft is inserted into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures. Receives: Device: The tunnel technique for root coverage with CTG andCross-linked Hyaluronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal parameters measured before surgery.
- Probing pocket depth (PPD) MEASURED IN MILIMETERS: distance from the gingival margin to the bottom of the gingival sulcus
- Clinical attachment level (CAL) MEASURED IN MILIMETERS: distance from the cementoenamel junction to the bottom of the gingival sulcus
- Recession height (RH) MEASURED IN MILIMETERS: distance from the cementoenamel junction to the gingival margin
- Width of keratinized tissue (WKT) MEASURED IN MILIMETERS: distance between the most apical point of the gingival margin and the mucogingival junction
- Gingival thickness (GT) MEASURED IN MILIMETERS: thickness of the gingiva measured 2-3 mm apical to the gingival margin
Measured: 1-7 days before surgery
Secondary outcomes (1)
Periodontal parameters measured after surgery.
- Probing pocket depth (PPD): distance from the gingival margin to the bottom of the gingival sulcus
- Clinical attachment level (CAL): distance from the cementoenamel junction to the bottom of the gingival sulcus
- Recession height (RH): distance from the cementoenamel junction to the gingival margin
- Width of keratinized tissue (WKT): distance between the most apical point of the gingival margin and the mucogingival junction
- Gingival thickness (GT): thickness of the gingiva measured 2-3 mm apical to the gingival margin
ALL ABOVE PARAMETERS ARE MEASURED IN MILIMETERS
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start15 Sep 2021
- Primary completion15 Sep 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Batlomiej Górski, PhD, Principal investigator, Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045586
- Sponsor's protocol ID
- WUM.Perio.03
- Status last verified
- Jun 2021
- First submitted
- 6 Sep 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gorski B, Skierska IM, Gelemanovic A, Roguljic M, Bozic D. Multiple Recessions Coverage Using the Modified Tunnel Technique and Connective Tissue Graft with or Without Cross-Linked Hyaluronic Acid: 2-Year Outcomes of RCT. J Funct Biomater. 2025 Mar 4;16(3):87. doi: 10.3390/jfb16030087.
PubMed 40137366Gorski B, Skierska IM, Nijakowski K, Brodzikowska A. Tunnel Technique and Subepithelial Connective Tissue Graft, With or Without Cross-Linked Hyaluronic Acid, in the Treatment of Multiple Gingival Recessions: Prognostic Parameters for Clinical Treatment Outcomes of Randomized Controlled Trial. J Clin Med. 2024 Nov 10;13(22):6758. doi: 10.3390/jcm13226758.
PubMed 39597902Skierska I, Gorski B, Fus L. Tunnel technique and subepithelial connective tissue graft, with or without cross-linked hyaluronic acid, in the treatment of multiple gingival recessions: 12-month outcomes of a randomized clinical trial. J Periodontol. 2024 Nov;95(11):1060-1072. doi: 10.1002/JPER.24-0093. Epub 2024 May 29.
PubMed 38808976
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Coronally Advanced Tunnel With Cross-linked Hyaluronic Acid in Addition to Connective Tissue Graft Compared With Subepithelial Connective Tissue Graft Alone for Treatment of Multiple Gingival Recession: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05045586
- Acronym / sponsor ID
- WUM.Perio.03
- Conditions
- Gingival Recession
- Keywords
- connective tissue graft, tunneling flap procedure, hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 15 Sep 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Microsurgical tunneling flap procedures using connective tissue grafts (CTG) are predictable for treating teeth with gingival recessions. Cross-linked hyaluronic acid can be used in conjunction with subepithelial palatal connective tissue grafts to improve postsurgical results. The aim of this study is to evaluate clinically the use of tunnel technique with CTG and cross-linked hyaluronic acid in addition to CTG alone for the treatment of multiple gingival recessions.
Detailed description
The treatment of multiple adjacent recession appears to be challenging for the clinician due to large surgical field, variation in teeth position in the dental arch (prominent roots), variation in recession size, thin phenotype and insufficient keratinized tissue in many teeth. Surgical treatment of all multiple recession in one dental arch during one session appears to be optimum. Surgical treatment time is longer, however patient doesn't need to undergo multiple surgeries, pharmacological therapies and postsurgical instructions. Esthetic concern seems to be one of the most common complaints from patients. Among utilized surgical techniques tunneling flap procedures using connective tissue grafts (CTG) with or without biologics such as an enamel matrix derivative (EMD) or hyaluronic acid (HA) provided the most successful outcomes for the treatment. Cross-linked hyaluronic acid can be used in conjunction with subepithelial palatal connective tissue grafts to improve postsurgical results and improving healing process. The aim of this study is to evaluate clinically the use of tunnel technique with CTG and cross-linked hyaluronic acid in addition to CTG alone for the treatment of multiple gingival recessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Coronally Advanced Tunnel With Connective Tissue Graft | Experimental | Device: The tunnel technique for root coverage with CTG without Cross-linked Hyaluronic AcidProcedure: A modified microsurgical tunnel technique by Zuhr et al. (2007). Initial sulcular incisions with a microsurgical blade are followed by a split-thickness buccal flap preparations using the tunneling knives. The preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The graft is inserted into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures. |
| MCAT With Cross-linked Hyaluronic Acid in Addition to CTG | Active comparator | Device: The tunnel technique for root coverage with CTG andCross-linked Hyaluronic AcidProcedure: A modified microsurgical tunnel technique by Zuhr et al. (2007). Initial sulcular incisions with a microsurgical blade are followed by a split-thickness buccal flap preparations using the tunneling knives. The preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The root surfaces are applied with cross-linked hyaluronic acid. The graft is inserted into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Bilateral multiple gingival recessions in homologous teeth
Key exclusion criteria (7 listed)
- Full-mouth plaque index ≥ 20% (Ainamo \& Bay 1975)
- Full-mouth sulcus bleeding index ≥ 15% (Mühlemann \& Son 1971)
- Smoking
- Systemic diseases with compromised healing potential of infectious diseases
- Drugs affecting periodontal health / healing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The tunnel technique for root coverage with CTG without Cross-linked Hyaluronic AcidThe tunnel technique for root coverage with CTG without Cross-linked Hyaluronic Acid | Device | Modified Coronally Advanced Tunnel With Connective Tissue Graft |
| The tunnel technique for root coverage with CTG andCross-linked Hyaluronic AcidThe tunnel technique for root coverage with CTG andCross-linked Hyaluronic Acid | Device | MCAT With Cross-linked Hyaluronic Acid in Addition to CTG |
Primary outcome
Periodontal parameters measured before surgery.
Time frame: 1-7 days before surgery
1. Probing pocket depth (PPD) MEASURED IN MILIMETERS: distance from the gingival margin to the bottom of the gingival sulcus 2. Clinical attachment level (CAL) MEASURED IN MILIMETERS: distance from the cementoenamel junction to the bottom of the gingival sulcus 3. Recession height (RH) MEASURED IN MILIMETERS: distance from the cementoenamel junction to the gingival margin 4. Width of keratinized tissue (WKT) MEASURED IN MILIMETERS: distance between the most apical point of the gingival margin and the mucogingival junction 5. Gingival thickness (GT) MEASURED IN MILIMETERS: thickness of the gingiva measured 2-3 mm apical to the gingival margin
1 secondary outcome
Periodontal parameters measured after surgery.
Time frame: 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Derived from this study: PubMed 40137366Gorski B, Skierska IM, Gelemanovic A, Roguljic M, Bozic D. Multiple Recessions Coverage Using the Modified Tunnel Technique and Connective Tissue Graft with or Without Cross-Linked Hyaluronic Acid: 2-Year Outcomes of RCT. J Funct Biomater. 2025 Mar 4;16(3):87. doi: 10.3390/jfb16030087.
- Derived from this study: PubMed 39597902Gorski B, Skierska IM, Nijakowski K, Brodzikowska A. Tunnel Technique and Subepithelial Connective Tissue Graft, With or Without Cross-Linked Hyaluronic Acid, in the Treatment of Multiple Gingival Recessions: Prognostic Parameters for Clinical Treatment Outcomes of Randomized Controlled Trial. J Clin Med. 2024 Nov 10;13(22):6758. doi: 10.3390/jcm13226758.
- Derived from this study: PubMed 38808976Skierska I, Gorski B, Fus L. Tunnel technique and subepithelial connective tissue graft, with or without cross-linked hyaluronic acid, in the treatment of multiple gingival recessions: 12-month outcomes of a randomized clinical trial. J Periodontol. 2024 Nov;95(11):1060-1072. doi: 10.1002/JPER.24-0093. Epub 2024 May 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Batlomiej Górski, PhD principal investigator
Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The tunnel technique for root coverage with CTG without Cross-linked Hyaluronic Acid and The tunnel technique for root coverage with CTG andCross-linked Hyaluronic Acid in people with Gingival Recession, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beata Wyrębek, PhD (+48692013589, beatawyrebek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal parameters measured before surgery. (time frame: 1-7 days before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05045586, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.